Computerized Cognitive Behavioral Treatment for Insomnia: Improving Rural Veteran Access to Evidence-Based Treatment to Reduce Suicide Risk (R-Vets Sleep)

NCT03365024 | Completed

• 1 other identifier: 17-1056
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

Insomnia is a major problem among veteran populations. Insomnia impacts physical and mental health functioning and is associated with reduced quality of life. Cognitive Behavioral Therapy for Insomnia (CBT-I) is one of the most promising treatments for insomnia; however, access to CBT-I is severely limited by a lack of trained clinicians within the Veterans Health Administration (VHA). There is a critical need to offer innovative approaches to meet the demand and need for insomnia treatment. Leveraging technology to meet treatment demands is consistent with service delivery models based upon stepped care principles. This randomized controlled trial will determine whether a computerized, self-guided, web-based version of CBT-I is efficacious in reducing insomnia symptoms and improving functioning compared to a computerized program control.

Conditions

Insomnia; Mental Health Functioning; Physical Health Functioning

Keywords

CBT-I; Insomnia

Outcome Measures

Primary Outcomes (6)

• Change in Insomnia Symptom Severity; Time 1 to Time 2

  The primary analysis will be the intent-to-treat comparison between groups of the change in insomnia symptom severity as measured by the Insomnia Severity Index (ISI) from Time 1 to Time 2. Statistical inference regarding the difference between intervention groups will be based on the estimated coefficient for a group indicator variable in each of three analysis of covariance models with the change from Time 1 to Time 2 for each outcome serving as the dependent variable. Additional covariates will include the baseline value of the outcome to improve the precision of the estimate, and any potential confounders discovered in the randomization check.

  Baseline and 9 weeks

• Change in Mental Health; Time 1 to Time 2

  The primary analysis will be the intent-to-treat comparison between groups of the change in Mental Health summary score, as measured by the Veteran's SF-36, from Time 1 to Time 2. Statistical inference regarding the difference between intervention groups will be based on the estimated coefficient for a group indicator variable in each of three analysis of covariance models with the change from Time 1 to Time 2 for each outcome serving as the dependent variable. Additional covariates will include the baseline value of the outcome to improve the precision of the estimate, and any potential confounders discovered in the randomization check.

  Baseline and 9 weeks

• Change in Physical Health ; Time 1 to Time 2

  The primary analysis will be the intent-to-treat comparison between groups of the change in Physical Health summary score, as measured by the Veteran's SF-36, from Time 1 to Time 2. Statistical inference regarding the difference between intervention groups will be based on the estimated coefficient for a group indicator variable in each of three analysis of covariance models with the change from Time 1 to Time 2 for each outcome serving as the dependent variable. Additional covariates will include the baseline value of the outcome to improve the precision of the estimate, and any potential confounders discovered in the randomization check.

  Baseline and 9 weeks

• Change in Insomnia Symptom Severity; Time 1 to Time 3

  A similar analysis will be performed for the above noted insomnia symptom severity outcome on the change from Time 1 to Time 3 to determine persistence of group differences to six-months post-intervention.

  Baseline and 6 Months

• Change in Mental Health; Time 1 to Time 3

  A similar analysis will be performed for the above noted Mental Health summary score, as measured by the Veteran's SF-36, on the change from Time 1 to Time 3 to determine persistence of group differences to six-months post-intervention.

  Baseline and 6 Months

• Change in Physical Health; Time 1 to Time 3

  A similar analysis will be performed for the above noted Physical Health summary score, as measured by the Veteran's SF-36, on the change from Time 1 to Time 3 to determine persistence of group differences to six-months post-intervention.

  Baseline and 6 Months

Study Arms (2)

Computerized Intervention 1

EXPERIMENTAL

A web-based program will deliver components of CBT-I on a time and event-based schedule. Pre and Post-Intervention assessments will be administered to determine the efficacy of the intervention.

Behavioral: Computerized Cognitive Behavioral Therapy for Insomnia

Computerized Intervention 2

ACTIVE COMPARATOR

A web-based program will deliver components of sleep education via an Internet platform. Pre and Post-Intervention assessments will be administered to determine the efficacy of the intervention.

Behavioral: Sleep Education

Interventions

Computerized Cognitive Behavioral Therapy for Insomnia BEHAVIORAL

A computerized insomnia intervention that employs the same behavioral, educational, and cognitive treatment components that underlie non-computerized CBT-I.

Also known as: cCBT-I

Computerized Intervention 1

Sleep Education BEHAVIORAL

A web-based program will deliver components of sleep education via an Internet platform

Computerized Intervention 2

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 89
• Eligible to receive care through VA ECHCS
• Reliable access to the Internet
• English speaking
• Able to provide informed consent
• Current insomnia diagnosis as defined by Diagnostic and Statistical Manual of Mental Disorders 5 (DSM 5) criteria

You may not qualify if:

• Currently enrolled in/participating in other intervention research studies
• Other untreated sleep disorders (e.g., sleep apnea, periodic limb movement)
• Currently receiving formal psychological treatment for insomnia (not including sleep medications)
• Past 3 month change in schedule and/or dosage of medications that are designed to improve/impact sleep
• History of Bipolar Disorder (with manic episodes), Schizophrenia, Schizoaffective Disorder, or a Psychotic Disorder
• Untreated seizures or seizure disorder
• Physical illness that is active, unstable, degenerative, and/or progressive
• Currently pregnant or plan to become pregnant in the next 6 months
• Irregular work schedule, shift work, and/or life changes (e.g., new baby) interfering with regular sleep patterns
• Significant cognitive impairment, as determined by chart review and/or during screening, that would interfere with ability to engage in SHUTi
• Current non-alcohol Substance Use Disorder, excluding Cannabis Use Disorder, as determined by chart review and/or self-report screen of drug use (\> 1 time) in past 3 months
• Current alcohol use diagnosis, as determined by SCID 5 module, in the past 3 months

Sponsors & Collaborators

• University of Colorado, Denver: lead
• US Department of Veterans Affairs: collaborator

Study Sites (1)

Rocky Mountain Regional VA

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Sarra Nazem, PhD

  VHAECH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2017
• First Posted: December 7, 2017
• Study Start: April 28, 2018
• Primary Completion: July 16, 2019
• Study Completion: July 16, 2019
• Last Updated: July 28, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)